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艾附暖宫软胶囊制备工艺研究
王健1, 张壮丽2, 杨海燕1, 李逢春1, 朱潇潇3, 顾宁宁3, 吴娟3, 张兴德3
1.河南省食品药品检验所, 郑州 450018;2.河南省医药科学研究院, 郑州 450052;3.南京中医药大学, 南京 210023
摘要:
[目的]对艾附暖宫软胶囊制备工艺进行优选。[方法]以流动性、均匀性和沉降体积比为考察指标,在单因素实验基础上,利用响应面软件Box-Behnken设计模型确定内容物的最佳工艺处方;以胶皮韧性和胶液黏性为指标,优化软胶囊囊皮处方;考察制备工艺,确定工艺参数。[结果]确定大豆油为分散介质,浸膏粉、大豆油、蜂蜡比例为1∶2.2∶6.25%,膏粉粒度为120目,制得的内容物混悬效果最好,以明胶、甘油、水比例为1∶0.4∶1的比例制备的囊皮效果最佳,胶盒温度50~60℃、喷体温度35~37℃,制冷温度为16~18℃,胶囊成形率和得率最高。[结论]优选的制备工艺合理,制剂稳定。
关键词:  艾附暖宫软胶囊  制备工艺  响应面
DOI:10.11656/j.issn.1672-1519.2018.10.17
分类号:R944.5
基金项目:河南省科技攻关项目(152102310131)。
Study on preparation technology of Aifu Nuangong soft capsule
WANG Jian1, ZHANG Zhuangli2, YANG Haiyan1, LI Fengchun1, ZHU Xiaoxiao3, GU Ningning3, WU Juan3, ZHANG Xingde3
1.Henan food and Drug Inspection Institute, Zhengzhou 450018, China;2.Henan Academy of Medical Sciences, Zhengzhou 450052, China;3.Nanjing University of Chinese Medicine, Nanjing 210023, China
Abstract:
[Objective] To optimize the preparation of AIfu Nuangong soft capsule.[Methods] On the basis of single factor experiment,with fluidity, uniformity and settlement volume ratio as index, the optimal process conditions were determined by Box-Behnken design as follows; the quality of capsule shells depending on the adhesive toughness and viscosity.[Results] Soybean oil is a good dispersing medium, and the ratio between drug soybean oil and beeswax is 1:2.2:6.25% can make sure the suspension system is best, and the best prescription of capsule shells was gelatin:glycerol:water=1:0.4:1. besides when the temperature of box is between 50~60℃,the temperature of the spray body is 35~37℃, and the cooling temperature is 16~18℃, the capsule is best.[Conclusion] The preparation process parameters are reasonable and the preparation is stable.
Key words:  Aifu Nuangong soft capsule  preparation technology  response surface methodology
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